Engineer II, Computer Systems Validation

Thermo Fisher Scientific • Greenville, NC

1d • Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges. About the Business Join our Pharma Services Group (PSG)—a global leader providing integrated drug development and manufacturing solutions to pharmaceutical and biotech companies. Our Greenville, North Carolina site specializes in sterile and oral solid dose (OSD) manufacturing, supported by advanced technologies and a highly collaborative team environment. Discover Impactful Work As an Engineer II, Computer Systems Validation (CSV), you will support validation activities tied to automation systems, manufacturing equipment, and computerized systems across the site. This role is primarily focused on change management and validation of existing commercial manufacturing systems, ensuring compliance and operational readiness. You will partner closely with automation, manufacturing, and quality teams to evaluate system changes, determine validation requirements, and execute qualification activities that maintain regulatory compliance and product quality.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field
• Equivalent combinations of education, training, and relevant experience may be considered in place of a degree
• Approximately 2 years of experience in validation, CSV, or a GMP-regulated environment
• Foundational understanding of cGMP and regulated environments
• Exposure to Computer Systems Validation (CSV), CQV, or automation validation
• Familiarity with automation/control systems (e.g., PLCs, SCADA, DCS, DeltaV, Allen-Bradley)
• Ability to support development of validation protocols (IQ/OQ/PQ)
• Strong technical writing and documentation skills
• Basic understanding of risk assessments and gap analysis
• Strong analytical and problem-solving skills
• Effective communication and collaboration skills
• Ability to manage multiple tasks in a fast-paced environment
• Proficiency with Microsoft Office tools
• Detail-oriented
• Collaborative team player
• Adaptable and flexible
• Strong communicator
• Quality and compliance focused

Nice To Haves

• Internship, co-op, or academic project experience in validation, automation, or regulated industries will also be considered
• Experience working with automation engineers or manufacturing systems
• Exposure to change management processes in regulated environments
• Familiarity with quality systems and validation lifecycle documentation

Responsibilities

• Evaluate changes to existing manufacturing systems, equipment, and related databases
• Support change management activities for commercial production lines
• Author and execute validation documentation including IQ/OQ/PQ protocols and qualification plans
• Perform risk assessments, validation assessments, and gap analyses to determine testing requirements
• Collaborate with automation and engineering teams to qualify system changes
• Support validation of automation and control systems (PLC, SCADA, DCS, DeltaV, etc.)
• Ensure compliance with cGMP, FDA, and industry standards
• Maintain accurate and compliant validation documentation
• Participate in continuous improvement and operational excellence initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees